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Randomized phase II study of 5-fluorouracil hepatic arterial infusion with or without antineoplastons as an adjuvant therapy after hepatectomy for liver metastases from colorectal cancer.

Ogata Y, Matono K, Tsuda H, Ushijima M, Uchida S, Akagi Y, Shirouzu K - PLoS ONE (2015)

Bottom Line: Antineoplaston A10 and AS2-1 reportedly control neoplastic growth and do not significantly inhibit normal cell growth.RFS was not significant (p=0.343).No serious toxicity, including bone marrow suppression, liver or renal dysfunction, were found in the AN arm.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, Kurume University Medical Center, Kurume, Japan.

ABSTRACT

Background: Antineoplastons are naturally occurring peptides and amino acid derivatives found in human blood and urine. Antineoplaston A10 and AS2-1 reportedly control neoplastic growth and do not significantly inhibit normal cell growth. Antineoplastons contain 3-phenylacetylamino-2, 6-piperidinedione (A10), phenylacetylglutamine plus phenylacetylisoglutamine (A10-I), and phenylacetylglutamine plus phenylacetate (AS2-1). This open label, non- blinded randomized phase II study compared the efficacy of hepatic arterial infusion (HAI) with 5-fluorouracil,with or without antineoplastons as a postoperative therapy for colorectal metastasis to the liver.

Methods: Sixty-five patients with histologically confirmed metastatic colon adenocarcinoma in liver, who had undergone hepatectomy, and/or thermal ablation for liver metastases were enrolled between 1998- 2004 in Kurume University Hospital. Patients were randomly assigned to receive systemic antineoplastons (A10-I infusion followed by per-oral AS2-1) plus HAI (AN arm) or HAI alone (control arm) based on the number of metastases and presence/ absence of extra-hepatic metastasis at the time of surgery. Primary endpoint was cancer-specific survival (CSS); secondary endpoints were relapse-free survival (RFS), status and extent of recurrence, salvage surgery (rate) and toxicity.

Findings: Overall survival was not statistically improved (p=0.105) in the AN arm (n=32). RFS was not significant (p=0.343). Nevertheless, the CSS rate was significantly higher in the AN arm versus the control arm (n=33) with a median survival time 67 months (95%CI 43-not calculated) versus 39 months (95%CI 28-47) (p=0.037) and 5 year CSS rate 60% versus 32% respectively. Cancer recurred more often in a single organ than in multiple organs in the AN arm versus the control arm. The limited extent of recurrent tumours in the AN arm meant more patients remained eligible for salvage surgery. Major adverse effects of antineoplastons were fullness of the stomach and phlebitis. No serious toxicity, including bone marrow suppression, liver or renal dysfunction, were found in the AN arm.

Interpretation: Antineoplastons (A10 Injection and AS2-1) might be useful as adjunctive therapy in addition to HAI after hepatectomy in colorectal metastases to the liver.

Trial registration information: ClinicalTrials.gov UMIN000012099.

No MeSH data available.


Related in: MedlinePlus

Relapse-free survival after hepatectomy.
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pone.0120064.g004: Relapse-free survival after hepatectomy.

Mentions: The median CSS time in the AN arm was significantly longer than that in the control arm (67 months (95%CI 43-not calculated) versus 39 months (95%CI 28–47) (p = 0.037) (Fig. 2). The 2-year, 5-year and 10-year CSS rates were 84%, 60% and 35% in the AN arm and 73%, 32% and 29% in the control arm. The OS was also longer in the AN arm than that in the control arm with median OS time 64.5 months (95%CI 38–92) vs 39 months (95%CI 28–47), although no significant difference was observed (p = 0.105) (Fig. 3). Three patients died in AN arm from other causes, pneumonia, acute myocardial infarction, other cancer and there was one accidental death in the control arm. However, there was no significant difference in RFS between the AN and control arms with median RFS 18 months versus 16 months, respectively (Fig. 4).


Randomized phase II study of 5-fluorouracil hepatic arterial infusion with or without antineoplastons as an adjuvant therapy after hepatectomy for liver metastases from colorectal cancer.

Ogata Y, Matono K, Tsuda H, Ushijima M, Uchida S, Akagi Y, Shirouzu K - PLoS ONE (2015)

Relapse-free survival after hepatectomy.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4366171&req=5

pone.0120064.g004: Relapse-free survival after hepatectomy.
Mentions: The median CSS time in the AN arm was significantly longer than that in the control arm (67 months (95%CI 43-not calculated) versus 39 months (95%CI 28–47) (p = 0.037) (Fig. 2). The 2-year, 5-year and 10-year CSS rates were 84%, 60% and 35% in the AN arm and 73%, 32% and 29% in the control arm. The OS was also longer in the AN arm than that in the control arm with median OS time 64.5 months (95%CI 38–92) vs 39 months (95%CI 28–47), although no significant difference was observed (p = 0.105) (Fig. 3). Three patients died in AN arm from other causes, pneumonia, acute myocardial infarction, other cancer and there was one accidental death in the control arm. However, there was no significant difference in RFS between the AN and control arms with median RFS 18 months versus 16 months, respectively (Fig. 4).

Bottom Line: Antineoplaston A10 and AS2-1 reportedly control neoplastic growth and do not significantly inhibit normal cell growth.RFS was not significant (p=0.343).No serious toxicity, including bone marrow suppression, liver or renal dysfunction, were found in the AN arm.

View Article: PubMed Central - PubMed

Affiliation: Department of Surgery, Kurume University Medical Center, Kurume, Japan.

ABSTRACT

Background: Antineoplastons are naturally occurring peptides and amino acid derivatives found in human blood and urine. Antineoplaston A10 and AS2-1 reportedly control neoplastic growth and do not significantly inhibit normal cell growth. Antineoplastons contain 3-phenylacetylamino-2, 6-piperidinedione (A10), phenylacetylglutamine plus phenylacetylisoglutamine (A10-I), and phenylacetylglutamine plus phenylacetate (AS2-1). This open label, non- blinded randomized phase II study compared the efficacy of hepatic arterial infusion (HAI) with 5-fluorouracil,with or without antineoplastons as a postoperative therapy for colorectal metastasis to the liver.

Methods: Sixty-five patients with histologically confirmed metastatic colon adenocarcinoma in liver, who had undergone hepatectomy, and/or thermal ablation for liver metastases were enrolled between 1998- 2004 in Kurume University Hospital. Patients were randomly assigned to receive systemic antineoplastons (A10-I infusion followed by per-oral AS2-1) plus HAI (AN arm) or HAI alone (control arm) based on the number of metastases and presence/ absence of extra-hepatic metastasis at the time of surgery. Primary endpoint was cancer-specific survival (CSS); secondary endpoints were relapse-free survival (RFS), status and extent of recurrence, salvage surgery (rate) and toxicity.

Findings: Overall survival was not statistically improved (p=0.105) in the AN arm (n=32). RFS was not significant (p=0.343). Nevertheless, the CSS rate was significantly higher in the AN arm versus the control arm (n=33) with a median survival time 67 months (95%CI 43-not calculated) versus 39 months (95%CI 28-47) (p=0.037) and 5 year CSS rate 60% versus 32% respectively. Cancer recurred more often in a single organ than in multiple organs in the AN arm versus the control arm. The limited extent of recurrent tumours in the AN arm meant more patients remained eligible for salvage surgery. Major adverse effects of antineoplastons were fullness of the stomach and phlebitis. No serious toxicity, including bone marrow suppression, liver or renal dysfunction, were found in the AN arm.

Interpretation: Antineoplastons (A10 Injection and AS2-1) might be useful as adjunctive therapy in addition to HAI after hepatectomy in colorectal metastases to the liver.

Trial registration information: ClinicalTrials.gov UMIN000012099.

No MeSH data available.


Related in: MedlinePlus